69101-600 : Hydrocodone Bitartrate and Acetaminophen Oral Solution

NDC:	69101-600
Labeler:	Burke Therapeutics, LLC
Product Type:	Human Prescription Drug
Drug Name:	Hydrocodone Bitartrate and Acetaminophen
Dosage Form:	Oral Solution
Application #:	ANDA040834
Rev. Date:	Mar 18, 2015
CSA Schedule:	CII (US) [1]

^[1] Schedule II / IIN Controlled Substance: High potential for abuse which may lead to severe psychological or physical dependence. (i.e. Narcotics such as Dilaudid, Methadone, Demerol, Oxycodone, Percocet, Fentanyl, Morphine, Opium, Codeine, and Hydrocodone ... Schedule IIN stimulants include non-narcotic Amphetamines such as Dexedrine, Adderall, Desoxyn, Methylphenidate (Ritalin) ... Other Schedule II substances include Amobarbital, Glutethimide, and Pentobarbital. More Details: US Dept of Justice Controlled Substance Schedules.

NDC Package Codes:

• 69101-600-08: 8 CUP, UNIT‑DOSE IN 1 TRAY (69101‑600‑08) > 15 ML IN 1 CUP, UNIT‑DOSE (69101‑600‑15)

Active Ingredients:

• Hydrocodone Bitartrate
• Acetaminophen

Pharmaceutical Classes:

• Opioid Agonist [EPC]
• Opioid Agonists [MoA]

Related Products:

Based on records with the same trade name.

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